title: Gender analysis of the pivotal results of the Medtronic Talent Thoracic Stent Graft System (VALOR) trial.
abstract: OBJECTIVE
  This study evaluated the differences between male and female patients undergoing thoracic endovascular aneurysm repair (TEVAR) in a pivotal Food and Drug Administration (FDA)-approved trial.
  
  
  METHODS
  The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) study was a prospective, nonrandomized, multicenter, pivotal trial conducted in the United States. Patients were enrolled between December 2003 and June 2005. Follow-up was conducted at 30 and 365 days.
  
  
  RESULTS
  VALOR enrolled 115 men (58.9%; 69.3 ± 11.7 years old), and 80 women (41.1%; 71.6 ± 10.1 years old). Iliac conduits were used more often in women, who had smaller diameter external iliac arteries, than in men (38.8% vs 8.8%, P < .001). Women required more blood transfusions and had a longer hospital length of stay. At 30 days, more major adverse events occurred in women than in men (52.5% vs 33.0%, P = .008), with more vascular access-related and respiratory complications. No gender-based differences were seen in all-cause mortality or in aneurysm-related death. The composite end point of 365-day "successful aneurysm treatment," defined as no aneurysm growth >5 mm at the 365-day follow-up visit compared with the 30-day follow-up visit and absence of any type I endoleak requiring a secondary procedure, favored women over men (98.2% vs 82.4%, P = .004).
  
  
  CONCLUSIONS
  TEVAR with the Talent device provided similar rates of 365-day mortality and morbidity for men and women. Although female patients had higher rates of periprocedural complications, they also more often had successful aneurysm treatment at the 1-year follow-up.
authors.affiliation: Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA. benjamin.jackson@uphs.upenn.edu
authors.forename: Benjamin M
authors.initials: BM
authors.lastname: Jackson
authors.forename: Edward Y
authors.initials: EY
authors.lastname: Woo
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bavaria
authors.forename: Ronald M
authors.initials: RM
authors.lastname: Fairman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017545:Aortic Aneurysm, Thoracic / Q000401:mortality / Q000601:surgery*; D001803:Blood Transfusion; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D057867:Endoleak / Q000209:etiology; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D012140:Respiratory Tract Diseases / Q000209:etiology; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States